Cleared Traditional

VEEGix EEG System

K240593 · Neuroservo, Inc. · Neurology

Aug 2024

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K240593 is an FDA 510(k) clearance for the VEEGix EEG System, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Neuroservo, Inc. (Montreal, CA). The FDA issued a Cleared decision on August 23, 2024, 175 days after receiving the submission on March 1, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K240593 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2024
Decision Date	August 23, 2024
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.